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Twin-screw melt granulation: Current progress and challenges.

Nada Kittikunakorn1, Tongzhou Liu1, Feng Zhang1

  • 1Division of Molecular Pharmaceutics and Drug Delivery, College of Pharmacy, The University of Texas at Austin, 2409, University Avenue, Austin, TX 78712, United States.

International Journal of Pharmaceutics
|August 3, 2020
PubMed
Summary

Twin-screw melt granulation (TSMG) offers consistent quality and advantages over traditional methods. This review details TSMG

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science
  • Chemical Engineering

Background:

  • Twin-screw melt granulation (TSMG) is an emerging continuous granulation technique.
  • It presents advantages over traditional wet and dry granulation methods in the pharmaceutical industry.
  • TSMG offers controlled temperature and shear, leading to consistent product quality.

Purpose of the Study:

  • To review the current advancements in twin-screw melt granulation.
  • To highlight the impact of formulation and process parameters on granule properties.
  • To discuss challenges and the need for mechanistic understanding in TSMG.

Main Methods:

  • Literature review of existing studies on twin-screw melt granulation.
  • Analysis of how various parameters influence granulation behavior and granule characteristics.
Keywords:
Continuous manufacturingMelt granulationTwin-screw melt granulation

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  • Discussion of process-induced physicochemical changes in drug substances.

    • Main Results:

    • TSMG produces granules with consistent quality due to its continuous nature and controlled processing conditions.
    • Formulation and process parameters significantly affect granulation behavior and final granule properties.
    • Process-induced changes in drug substances remain a challenge requiring further investigation.

    Conclusions:

    • Twin-screw melt granulation is a promising continuous manufacturing technology for pharmaceuticals.
    • A deeper mechanistic understanding is needed to overcome challenges related to process-induced drug substance changes.
    • Optimizing formulation and process parameters is key to leveraging TSMG benefits.